The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services globally to companies within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery, API manufacture, formulation and analytical development, clinical trial supply, IRT technology through to product launch, commercial drug product manufacture and packaging.
Only Almac can combine the expertise, from our specialised teams, to provide you with the right service solutions to help you across the full biopharmaceutical product lifecycle, from development through to commercialisation.
We are a privately owned organisation that has organically grown over 50 years and now employs in excess of 5,000 high skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with 17 global facilities in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Through our continual investment in the expansion of our state of the art services; from new world-class, 220,000ft2 pharmaceutical development facilities complete with dedicated high potency processing suites through to specialised packaging solutions supporting complex kit assembly and serialisation, Almac ensures we are always there to support you across the product development lifecycle.
2661 Audubon Road
Audubon, PA 19403
Phone: 610 666 9500
Fax: 610 666 8551
Contact: Adam Schroeder
Read the latest Q&A from Dawn Douglas, Qualified Person at Almac Pharma Services. This Q&A looks at the key quality considerations when launching a product into the EU. Topics discussed include what the role of a qualified person involves, key milestones when launching a product into the EU market, and quality licencing requirements when launching a product into the EU.
Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported a £17M rise in turnover from £531M to £548M for 2017-18. Pre-tax profits were recorded at £27M whilst average employee figures increased by 8% from 4,407 to 4,798 for the same period.
Turning Point Therapeutics, Inc., a precision oncology company developing novel drugs that address treatment resistance, and Almac Diagnostic Services, a global stratified medicine company, recently announced approval by the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the diagnostic assay that will be used in Turning Point’s registrational phase 2 clinical study.
Learn how streamlining operations and using a process called Late Stage Customization you can significantly reduce costs to ensure a more efficient, flexible supply chain.
Almac explains how, through the use of the Hapa BlisterJet printer, they are able to maximize the stock flexibility of their clients’ valuable orphan drug products, meaning they can distribute product more efficiently between different European countries.
Almac Group, the global contract development and manufacturing organisation, is delighted to announce it has won awards in all core categories for 2019 for excellence in Quality, Reliability, Capabilities, Expertise, Compatibility, and Service.
Almac Sciences, a member of the Almac Group, has announced a collaboration with Science Exchange, the world’s leading R&D Services Management company.
After successfully outsourcing an initial chemistry, manufacturing, and controls (CMC) project, a global Big Pharma company sought a more strategic CMC outsourcing partnership.
Almac Sciences, a member of the Almac Group, has expanded its technology capabilities within its Active Pharmaceutical Ingredients (API) services & chemical development portfolio with the implementation of continuous flow expertise at its global headquarters in Craigavon, UK, with further plans to introduce flow capacity within Arran Chemical Company (Athlone, Ireland).
Galen Ltd, the Northern Ireland based pharmaceutical company, is delighted to announce the appointment of Dr Dennise Broderick as its new Managing Director and President. She will report to Alan Armstrong, CEO and Chairman, Almac Group, - the parent company of Galen Ltd.
Almac Group, the global contract development and manufacturing organisation, is delighted to announce that they have brought online a second stream for High Throughput GMP Peptide manufacturing.
Although rare diseases are characterised by low prevalence individually, the total number of people affected by rare diseases in the EU is estimated at between 27 and 36 million.
Almac Group, the global contract pharmaceutical development and manufacturing organisation, has reported a 19% rise in revenue to £531M.
Company launches a fast acting Insulin injector pen pharmaceutical kit into the U.S. market by utilizing the new bespoke Semi-automated Packaging System (SAPS) at Almac’s U.S. commercial packaging facility.
Almac Group, the global contract pharmaceutical development and manufacturing organisation, is pleased to announce that it has expanded its US commercial packaging capabilities at its Audubon, PA facility.
To be able to market a medicinal product in Europe, you must obtain a Marketing Authorization (MA) from the relevant regulatory authority. There are a number of different routes to apply for an MA.
A global speciality healthcare company benefited completed technology transfer, CBE-30 approvals and finished pack commercial supply within a 10 month timeframe.
The pharma industry is increasingly looking for approaches that shorten drug development timelines and save on cost, especially virtual biotech companies who rely heavily on key milestone payments.
A US biopharmaceutical company approached Almac to assist with the EU product launch of their high value, temperature sensitive, orphan drug product.
Regulatory recommendations for a Pediatric Investigation Plan (EU) or Pediatric Study Plan (U.S.) have led to a significant increase in demand for pediatric dosage form development and commercialization.
Ironwood sought a CMO for its novel linaclotide drug product, requiring the CMO to transfer, scale-up manufacture and package its product to meet an aggressive regulatory timeline.
A pharma company recognized the importance of partnering with an experienced, full service CMO to guide them through the complexities and toward the successful launch of their product.
Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.
Child resistant packaging intergrates the use of safety mechanisms and physical barriers to reduce the risk of poisining in children via the ingestion of potentially hazardous medicines.
Helping you to be better prepared for what is ahead and ensure your commercial launch is successful, our subject matter experts will guide you through the EU launch process, from submitting your MAA, to final distribution of drug product to the end-user.
Almac has developed a flexible pediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner, Amicus Therapeutics on the European approval of its first orphan drug product and precision medicine Galafold™ (migalastat, also referred to as AT1001).
Almac Group, the global contract development and manufacturing organisation, wishes to congratulate its long-term client partner Intercept Pharmaceuticals, Inc. on the U.S. Food and Drug Administration (FDA) approval of their first orphan drug product obeticholic acid, marketed in the US as Ocaliva®.
Almac Group, the global contract development and manufacturing organisation, is pleased to announce an expansion to its serialisation capabilities to include its US commercial packaging facility in Audubon, PA.
This video highlights Almac’s world-class Charnwood campus facilities which currently have over 1,500m2 of readily available GMP floor space that can be customized to suit the specific needs of their client partners.
Launching a product into Europe but unsure about the different requirements for a European market? Join our experts in September at our EU Product Launch Workshop series: Key timeline milestones from phase 3 to launch, where they will guide you through an EU product launch.
Specialized packaging solutions to address the increasing focus of developing and bringing more advanced medicines and niche orphan drugs to market.
In response to increasing client demand, contract development and manufacturing organization expandes its pharmaceutical drug product development services in the UK through the addition of two linked facilities within the Charnwood Campus, in Loughborough, England.
This short video displays the new semi-automated packaging system (SAPS) - a packaging solution for an array of kit packs including medical device kits and parenteral delivery forms.
Commercial packaging provider addresses client needs of bringing more advanced medicines and orphan drugs to the market.
This video explains how 3PL and 3PF solutions help simplify the supply chain with orders being received direct from the end-user hospital/pharmacy and product being delivered within 24-48 hrs.
A discussion of shipment validation protocols for temperature-sensitive drug products and conducting a risk assessment to design a bespoke shipping solution for your valuable orphan drug.
This article discusses what you need to take into consideration to strike the balance between the function of packaging with regulatory and market requirements.
An explanation of packaging regionalization strategies and how using regional packs, coupled to blue box, late-stage labelling operations can minimize stock holding and maximize its flexibility.
In explanation of Almac’s approach to meeting the various global requirements and experience of implementing serialization solutions to meet client needs.
This short video will help you navigate the various quality launch requirements to ensure you are compliant with EU regulations and your launch plan runs smoothly.